To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.
Aim 1. We will test our hypothesis that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (NIH Toolbox, PennCNB, and MSCEIT) and social skills (SSPA). For study Aim 1, we hypothesized that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (selected NIH Toolbox and Penn CNB measures, and MSCEIT) and social skills (SSPA). Aim 2: We will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, we hypothesize that patients with less impairment in cognitive functioning at baseline will demonstrate relatively larger treatment gains in SST compared to those in CET than those who are initially more cognitively impaired, and that younger patients will benefit more from CET compared to those in SST than those who are older. The results of this study will address a key knowledge gap in the field and a decisional dilemma for clinicians. A pilot study at four treatment sites will be used to test the feasibility and acceptability of telementalhealth delivery of these two treatments, as compared to in-person delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
CET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both.
The psychosocial component involves weekly skills training classes delivered over one year, with modules including "Communicating Effectively," "Making and Keeping Friends," "Making the Most of Leisure Time," "Healthy Living," "Using Medications Effectively," and "Making the Most of a Health Care Visit" (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises.
Hartford Hospital - Institute of Living
Hartford, Connecticut, United States
RECRUITINGMaine Medical Center
Portland, Maine, United States
RECRUITINGMassachusetts Mental Health Center
Boston, Massachusetts, United States
Change in Social Adjustment Scale II
Measure of social functioning
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Heinrich Quality of Life Scale
Measure of social functioning
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Social Skills Performance Assessment
Measure of social functioning using role played scenarios
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Auditory Verbal Learning Test
Neurocognition measure of verbal ability in NIH Toolbox
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in List Sorting Working Memory
Neurocognition measure of working memory in NIH Toolbox
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Positive and Negative Syndrome Scale, PANSS-6
Short form of measure of positive and negative symptoms
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Picture Sequence Memory
Neurocognition measure of visual/episodic memory \& learning in NIH Toolbox
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Picture Vocabulary
Neurocognition measure of language in NIH Toolbox
Time frame: Measurement at 0, 6, 12, 18, 24 months
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
ACTIVE_NOT_RECRUITINGUMass Medical School
Worcester, Massachusetts, United States
RECRUITINGChange in Oral Reading Recognition
Neurocognition measure of language in NIH Toolbox
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Mouse Practice Test
Neurocognition measure of speed of processing in PennCNB
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Digit Symbol Test
Neurocognition measure of speed of processing in PennCNB
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Conditional Exclusion Test
Neurocognition measure of reasoning \& problem solving in PennCNB
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Penn Continuous Performance Test
Neurocognition measure of reasoning \& problem solving in PennCNB
Time frame: Measurement at 0, 6, 12, 18, 24 months
Change in Managing Emotions
Subscale of the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT)
Time frame: Measurement at 0, 6, 12, 18, 24 months